News | September 08, 2010

ICD Complication Rate Dropped According to National Registry

September 8, 2010 – Total complications for new implantable cardioverter defibrillator (ICD) implants (including death in the laboratory) have decreased from 3.77 percent in 2006 to 2.87 percent in 2009, according to new data from the National ICD Registry.

The repository of ICD implantation data was developed through a partnership of the Heart Rhythm Society and the American College of Cardiology Foundation. It just released its 2009 report. This is the fourth annual review of the registry and is published in the September edition of the HeartRhythm Journal, the official Journal of the Heart Rhythm Society.

The annual report includes data that spans more than four years and is the largest repository for ICD implantation data. The Registry is accruing ICD implants at the rate of 10,000 per month with 79 percent of implants in the registry being performed in hospitals that enter all data on patients regardless of device indication or patient age. Thus, approximately 90 percent of all ICD implants performed in the United States are entered into the registry. As of December 2009, the fourth annual report includes data from 486,025 ICD implantations from 1,434 participating hospitals and 5,246 implanting physicians. This represents an increase of participating hospitals and implanting physicians from the annual report 2008 and demonstrates the registry’s continued growth.

“Gathering data for inclusion within the National ICD Registry is critical for us to better understand the application of ICD therapy and, more importantly, to improve patient care,” said Douglas L. Packer, M.D., FHRS, president of the Heart Rhythm Society. “The ICD Registry is an extensive reporting measure that continues to evolve and enhance its data to offer physicians better insight into device procedures and offer rich data for continued and more effective research.”

Key Findings

The information collected is used to determine best practices for ICD therapy in the general population including gender differences in procedural-related adverse events, racial and ethnic differences in cardiac resynchronization therapy (CRT) and the association of physician certifications and outcomes.

• Total complications for new implants (including death in the laboratory) have decreased over time from 3.77 percent in 2006 to 2.87 percent in 2009.

• Medicare beneficiaries accounted for 68 percent of patients.

• The device was placed for primary prevention in 78 percent of patients, two-thirds with coronary artery disease, the average left ventricular ejection fraction (LVEF) was 29 percent, and 82 percent were New York Heart Association (NYHA) Class II-III.

• Among physicians that provided information about their training, 56 percent completed an electrophysiology fellowship, accounting for 83 percent of ICD implants.

• Of patients receiving cardiac resynchronization therapy with defibrillation backup (CRT-D), 68 percent were shown to meet published national guidelines.

• Of patients receiving an ICD for primary prevention of sudden death, 78 percent met published national guidelines.

New Data Being Collected
In April 2010, version 2.0 of the registry was initiated and began collecting data on leads associated with ICD implantation and pediatric ICD implants. The ICD Registry working group and the Pediatric and Congenital Electrophysiology Society (PACES) have collaborated to provide data on pediatric and congenital patients providing insight into unique clinical issues affecting pediatric patients receiving an ICD. The data will continue to evolve and mature as the registry now includes data on atrial, ventricular, defibrillation, left heart, and epicardial leads placed at the time of ICD implant and whenever existing leads are repositioned, replaced, extracted or abandoned. The registry is positioned to serve as a tool for performance measure reporting in combination with data from Medicare claims.

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